Associate Operations Support Specialist
NAMSA pioneered the industry, NAMSA was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry.
We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization whose:
- Mission is to make a scientific contribution to every medical device in the world.
- Culture is passionately committed to the partnership between one another and our clients to improve and save lives through a respectful, trusting, and collaborative environment.
- Values have stood the test of time.
- Above all else, conduct ourselves with integrity
Job Description:
- Assists in the development of daily startups worksheets.
- Monitors animal use as related to startups tasks (i.e. prior medication, sedation, etc.).
- Independently builds and reviews forms and specimen labels to ensure all protocol requirements such as pre and post-operative medications, specimen collection, and other protocol specific tasks are clearly and accurately communicated to Associates.
- Transports specimens between buildings, ensuring that storage requirements are met for all samples. Verifies accuracy of sample documentation, including labels and paperwork at time of transport.
- Assists with management of specimens collected during study conduct, including inventory control and shipping per study instructions.
- Assists with study article management, including inventory control and shipping, throughout study duration.
- Assist in building study schedules in miscellaneous scheduling software.
- Develops and maintains daily startups worksheets; works with department managers to ensure all necessary study specific requirements are scheduled for the appropriate technician group.
- Assists in scheduling pre-study meetings for complex studies via collaboration with applicable department managers.
- Assists with animal procurement process, including but not limited to, vendor approval and monitoring, procurement, scheduling pre-study activities (i.e. acclimation & screenings) and assignment to study.
- Assists with animal management, including but not limited to: monitoring ongoing animal use (i.e. prior medication, sedation, etc.), assignment/enrollment, and tracking animal abnormalities within the animal’s database.
- Assists in developing, reviewing and updating applicable SOPs and other technical documents to reflect current policies and practices.
- Assists in communications with scheduling, business development, quoting and finance departments to ensure preparedness for upcoming studies.
- Builds study schedules in appropriate scheduling software.
- Other duties as assigned
Qualifications & Technical Competencies/Principal Duties and Responsibilities:
- Job Profile Summary
- Assists in the development of daily startups worksheets.
- Monitors animal use as related to startups tasks (i.e. prior medication, sedation, etc.).
- Independently builds and reviews forms and specimen labels to ensure all protocol requirements such as pre and post-operative medications, specimen collection, and other protocol specific tasks are clearly and accurately communicated to Associates.
- Transports specimens between buildings, ensuring that storage requirements are met for all samples. Verifies accuracy of sample documentation, including labels and paperwork at time of transport.
- Assists with management of specimens collected during study conduct, including inventory control and shipping per study instructions.
- Assists with study article management, including inventory control and shipping, throughout study duration.
- Assist in building study schedules in miscellaneous scheduling software.
- Other duties as assigned
Qualifications and Skills:
- One year of experience in an animal laboratory setting.
- Medical device research experience, with knowledge of and experience with operational processes and functions of a preclinical setting preferred.
- Knowledge of AAALAC, USDA, FDA, ISO, USP, JMLWH and GLP regulations preferred.".
- Associate or Bachelor’s degree in biological sciences or related field required.
Working Conditions:
- While performing the duties of this job, the employee is regularly exposed to general office working conditions and will be required to regularly work on personal computers and keyboards. The employee is regularly exposed to a variety of livestock, domestic and laboratory animals. The employee is occasionally be exposed to fluoroscopy, radioactive isotopes, BSL2 bacteria and viruses in a controlled environment, and may, on rare occasion, be exposed to zoonotic diseases. The employee is frequently exposed to outdoor weather conditions due to moving between buildings.
- The noise level in the work environment is usually moderate. "
- While performing the duties of this job, the employee is regularly required to bend, stoop, twist, stand, walk, use hands, talk, and hear and view computer monitors. The employee is frequently required to reach with hands and arms, and use fingers. The employee must occasionally lift and/or move up to 50 pounds.